ASTM F640 - 12 - Standard Test Methods for Determining Radiopacity for Medical Use

ASTM F640 - 12

Standard Test Methods for Determining Radiopacity for Medical Use

Status : Current   Published : December 2012

Format
PDF

Format
HARDCOPY



1.1 These test methods cover the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography) and DEXA (dual energy X-ray absorptiometry), also known as DXA, The results of these measurements are an indication of the likelihood of locating the product within the human body.

1.2 Radiopacity is determined by ( a) qualitatively comparing image(s) of a test specimen and a user-defined standard, with or without the use of a body mimic, or ( b) quantitatively determining the specific difference in optical density or pixel intensity between the image of a test specimen and the image of a user-defined standard, with or without the use of a body mimic.

1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.4  This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.




Standard NumberASTM F640 - 12
TitleStandard Test Methods for Determining Radiopacity for Medical Use
StatusCurrent
Publication Date15 December 2012
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors Implants, Radiopacity, Surgical applications, Surgical devices, Surgical implants, Test methods, X-ray
ICS11.040.40
11.120.01
PublisherASTM
FormatA4
DeliveryYes
Pages4
File Size87 KB
Price£36.00


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